Whitney,
As with any quality system linkage, I would strongly recommend that you incorporate the UDI number of a medical device into your service reports. As you are probably aware from 820.200 (d)(2) there is a requirement to include any UDI number or any other device identification or control number. This can be done a number of ways such as manually entering the UDI number or the field service engineer has their own bar code reader that auto loads the UDI number into their system. When servicing of a device is performed whether for preventive maintenance, service repair, or service upgrade that the UDI number of the device is captured in the service report. I worked with one company where their field service engineers capture the information on a laptop/tablet. They added one field for UDI. So when the field service engineer performs a service on an instrument either at the customer site or returned to the company for repair; they enter the model number of device, serial number of device, and UDI number of device (from the human readable format) for the device identification. They talked about getting rid of the separate serial number, since this would already be incorporated into the UDI as the PI information, but something for them in the future.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 06-Aug-2018 09:28
From: Whitney Davis
Subject: UDI Requirements for 21 CFR 820.200 Serving
I am trying to better understand the requirements for documenting UDI or UPC on service reports for medical devices. What is required? The UDI number, bar code, etc.? We are in the process of updating our service reports as we move to a cloud based reporting system. What are others doing to meet this requirement?
Whitney Davis
Quality Specialist III
Instrument and Enterprise Services
Thermo Fisher Scientific
401 Millcreek Road | Marietta, OH 45750
Tel: +1 (740) - 568-5798 | Mobile: (304) 893-4442
whitney.davis@thermofisher.com | www.thermofisher.com
"The World Leader In Serving Science"
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